iRadimed Corp 2025年季度报告

Page Cautionary NoteRegarding Forward-Looking Statements “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the Securities Litigation Reform Act of 1995. When used in this Quarterly Report the words “believe,” “targets,” “estimates,” “projects,” “plans,” and “potential,” and other similar words and expressions of the future, are intended to identify such forward-looking statements, but other statements not basedon historical information may also be considered forward-looking, including statements about theCompany’s future financial and operating results and the Company’s plans, objectives, and intentions.All forward-looking statements are subject to risks, uncertainties, and other factors that may cause theactual results, performance, or achievements of the Company to differ materially from any results,performance, or achievements expressed or implied by such forward-looking statements.Theseforward-looking statements are subject to known and unknown risks, uncertainties and other factorsthat could cause the actual results to differ materially from the statements, including, but not limitedto:●our ability to receive 510(k)clearance for our products and product candidates,complete inspections conducted by the U.S. Food& Drug Administration (the “FDA”)or other regulatory bodies resulting in favorable outcomes, additional actions by orrequests from the FDA, including a request to cease domestic distribution of products,or other regulatory bodies and unanticipated costs or delays associated with theresolution of these matters;●the timing and likelihood of regulatory approvals or clearances from the FDA or otherregulatory bodies and regulatory actions on our product candidates and productmarketing activities;●unexpected costs, expenses and diversion of management attention resulting fromactions or requests posed to us by the FDA or other regulatory bodies;●failure to obtain and/or maintain regulatory approvals or clearances and comply withapplicable regulations; and investors;●our ability to compete in the development and marketing of our products and productcandidates with existing companies and new market entrants in our industry;●difficulties or delays in the development, production, manufacturing and marketing ofnew or existing products and services, including difficulties or delays associated withobtaining requisite regulatory approvals or clearances associated with those activities;●changes in laws and regulations or in the interpretation or application of laws orregulations, as well as possible failures to comply with applicable laws or regulations asa result of possible misinterpretations or misapplications;●cost-containment efforts of our customers, purchasing groups, third-party payers andgovernmental organizations; ●increasing and/or fluctuating tax and interest rates as well as inflationary pressures onthe U.S. and global economies;●geopolitical risks, including tariffs, trade disputes, international conflicts and recent or Forward-looking statements should, therefore, be considered in light of various factors, includingthose set forth under “Part I, Item 2. Management's Discussion and Analysis of Financial Conditionand Results of Operations,” “Part II, Item 1A. Risk Factors,” and elsewhere in this Quarterly Report,and under “Part I, Item 1A. Risk Factors” and “Part II, Item 7. Management's Discussion andAnalysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K forthe fiscal year ended December31,2024 (the “2024 Annual Report”) and those set forth from time totime in our other filings with the SEC. These documents are available through our website or throughthe SEC's Electronic Data Gathering and Analysis Retrieval system at http://www.sec.gov. In light of Report to “IRADIMED,” the “Company,” “we,” “our,” and “us” refer to IRADIMEDCORPORATION. Additional The accompanying interim condensed financial statements of IRADIMED CORPORATION financial statements prepared in accordance with U.S. generally accepted accounting principles(“GAAP”) have been condensed or omitted pursuant to such rulesand regulations. The interim financial information is unaudited, but reflects all normal adjustments that are, in the opinion ofmanagement, necessary for the fair presentation of our financial position, results of operations andcash flows for the interim periods presented. Operating results for the three months endedMarch31,2025 are not necessarily indicative of the results that may be expected for theyear endingDecember31,2025, and other interim periods, or futureyears or periods. those described in Note1 to the Financial Statements in the 2024 Annual Report.We operate inonereportable segment, which develops, manufactures, markets, sells, anddistributes Magnetic Resonance Imaging (“MRI”) compatible medical devices and products, related Certain Significant Risks and UncertaintiesWe market our products to end users in the United States